Job Description

Job Description

Job Description

Salary:

Join our fast-growing US team as a Senior Clinical Data Manager , where you’ll play a critical role in advancing drug and vaccine development programs. We’re seeking an experienced professional with deep expertise in data management processes, project management, and computer systems to oversee all aspects of data management activities.

In this role, you will lead, plan, and execute data management tasks for assigned projects, ensuring data integrity, validity, and reliability. You’ll work in alignment with KCR standard operating procedures, industry best practices, and regulatory requirements while producing high-quality documentation to support these activities.

If you have strong initiative, project management, and organization skills, and the ability to collaborate effectively across functional teams, global customers, and vendor partners, we’d love to hear from you!

Position: Senior Clinical Data Manager – recent CRO experience Required.

Location Details: Home-based; United States; Remote CONUS: EST Eastern or Central CST Time Zone preferred.

Travel: up to 10% (Available for travel, including overnight stays, as needed) 

KCR is a clinical development solutions provider creating value for biotechnology and pharmaceutical organizations. Founded in 1997, our expert teams support clients with full-service clinical development capabilities across three main areas: Trial Execution, Consulting and Placement. KCR operates across North America, Europe, and Australia, with main office locations in Boston US, Berlin Germany, Madrid Spain and Warsaw Poland. Our geographical coverage across 25+ countries, cutting-edge technical capabilities and tailored offerings allow for the optimized delivery of solutions to develop life-changing therapies. KCR offers access to an estimated population of 1.1 billion people.

For more information visit 

We see human behind every number.

The duties associated with the role include:

• Holds ownership of all study level KCR data management deliverables, which may include any of the following: data receipt, data entry, initial and final data review, management of data from external sources and discrepancy resolution following KCR data management SOPs and ICH/GCP practices
• Responsible for all aspects of project specific electronic data management system development including: CRF/eCRF set-up, collector design, edit definitions, report requirement definitions, requirement documentation and testing
• Oversees preparation and execution of all tasks associated with database lock and archival
• Generates and maintains high quality data management documentation in accordance with KCR data management SOPs
• Assumes ownership for DM deliverables including creation and management of DM-specific project plans, timelines and providing resource projections
• Develops, generates, and analyzes project status and/or metric reports, summarizes and reports findings and remediation activities to internal and external stakeholders
• Holds vendor oversight and management with respect to data management deliverables; ensuring selected vendor meets service level commitments
• May interact with investigational sites for data discrepancy resolution at a global level
• Participates in new project cost estimates, proposal review, proposal defense and capabilities presentations with minimal oversight
• May support any other project or perform any other data management task deemed appropriate by management

Requirements:

• Bachelor's degree in life sciences/pharmacy/biotechnology, nursing from an accredited US College/University.
• At least 5 years of professional data management experience, preferably in pharmaceutical, biotechnology, or CRO industry with recent CRO experience given top priority.
• Experience with Oncology study data, other Therapeutic areas beneficial.
• Strong knowledge of monitoring guidelines, SOPs, GCP/ICH and applicable Guidelines.
• Deep knowledge of late-stage clinical data management process; study start- up/execution/database lock.
• Expert computer systems literacy, and adaptable to new technologies
• Experienced user with multiple data collection systems including electronic data capture (EDC) technologies such as ePRO or eCOA, IRT, and at least one EDC tool such as Veeva CDMS, Medidata Rave, InForm, Oracle Clinical, Clincase, etc.
• Excellent professional command of English language, written and spoken.
• Ability to execute tasks in an accurate and timely manner with an emphasis on quality, organization, coordination, and project management.

At KCR we put our mission: WE SEE HUMAN BEHIND EVERY NUMBER into our actions, therefore we offer our Employees benefits that comply with national regulations and provide the coverage that best meets employee needs.

To demonstrate how appreciated your talent and your commitment are, KCR is offering you:

• 33 PTO days (inclusive of recognized holidays)+ 1 additional for your birthday
• A valuable healthcare and wellbeing benefits package (private health plans, life insurance, travel insurance, disability insurance, private retirement fund) plus additional discount programs
• Loyalty and Referral Programs 
• Onboarding process and induction training to develop deep sector knowledge and complex skills.
• Latest technology and the most advanced equipment and working tools.
• An open culture based on slim processes, in an agile structure with a flat hierarchy and direct access to the Management to share ideas and implement change and continuous improvement.
• Mentoring and training programs related to clinical trials, therapeutic areas, hard and soft skills.

Our Privacy Policy

As KCR became part of the ICON group, your personal data will be shared with ICON and processed in accordance with privacy notice: -applicants. If you want your candidacy to be considered also for future recruitments, please send us an additional consent: “I agree to the processing of my personal data for any future recruitments conducted by ICON”. Such consent may be placed in your CV or electronic correspondence addressed to us. You can withdraw your consent at any time. Withdrawal of consent does not affect the legality of the processing carried out prior to its withdrawal.

KCR is an equal opportunity employer. In line with our motto, ‘We see human behind every number,’ KCR is committed to fostering an inclusive culture and maintaining a diverse, safe, and respectful working environment with equitable treatment for all. We are committed to non-discriminatory practices and provide an equal opportunity for all qualified employees and job applicants within all employment sects. We believe that in developing a desirable culture of belonging in which diverse perspectives and voices are welcomed and heard, the full potential of employees can be achieved.

***This requisition is not open to agency solicitation***

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